Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay
Reported: October 26, 2022 Initiated: September 19, 2022 #Z-0105-2023
Product Description
Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay
Reason for Recall
Potential for falsely elevated LITH_2 and Li results on the Atellica CH 930 Analyzer. In the worst case, there is a potential for erroneously elevated lithium patient results, which may lead to inappropriate dosage adjustment, potentially affecting treatment efficacy.
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc.
- Units Affected
- 586 US; 694 OUS
- Distribution
- Worldwide distribution - US Nationwide.
- Location
- Tarrytown, NY
Frequently Asked Questions
What product was recalled? ▼
Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 586 US; 694 OUS.
Why was this product recalled? ▼
Potential for falsely elevated LITH_2 and Li results on the Atellica CH 930 Analyzer. In the worst case, there is a potential for erroneously elevated lithium patient results, which may lead to inappropriate dosage adjustment, potentially affecting treatment efficacy.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 26, 2022. Severity: Moderate. Recall number: Z-0105-2023.
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